Clinical Trial: Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins

Brief Summary: Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.

Detailed Summary:
Sponsor: University of New Mexico

Current Primary Outcome: Change in blood brain barrier permeability over three months for the treatment group compared to the control group. [ Time Frame: Baseline, Three Months ]

We will measure the change in blood brain barrier permeability with dynamic contrast enhanced MRI from baseline to three months. We will compare the change in permeability for a group of CCM patients placed on statin medication (treatment group) with a group of CCM patients not on statin medication (control group).


Original Primary Outcome: Same as current

Current Secondary Outcome: Correlation of physiologic permeability data with anatomic lesion data [ Time Frame: Baseline, Three months ]

Use dynamic contrast-enhanced MRI to detect abnormalities in brain permeability in CCM patients and correlate with anatomic lesion information.


Original Secondary Outcome: Same as current

Information By: University of New Mexico

Dates:
Date Received: January 7, 2013
Date Started: March 2012
Date Completion:
Last Updated: April 7, 2016
Last Verified: April 2016